EC rejects generic hGH

The European Commission has rejected an application by Sandoz, a unit of Novartis (NVS; SWX:NOVN), to market Omnitrop, a biosimilar (generic) version of human growth hormone (hGH). Sandoz was notified in November 2003 that the EC rejected its Omnitrop application, according to a document released by the EC on March 20. Sandoz and the EC have not previously disclosed the rejection.

The EC decision was unusual because it overturned a June 2003 recommendation by the Committee for Proprietary Medicinal Products (CPMP) to approve Omnitrop to treat growth disturbance in children aged three and older. The company has launched a legal action against the EC in an effort to overturn the rejection. ...